There might be a theory that with the recent large financial settlements in the pharmaceutical industry, messages have been sent and behaviors changed permanently. However, with governments running ever larger deficits, and a focus on healthcare policy, a more reasoned theory might suggest enhanced government focus, new prosecution theories, and more sophisticated investigation techniques. This, juxtaposed against companies with challenging top and bottom line targets, downsizings, merger integration activity, and reorganizations, has the potential to create even greater challenges for compliance professionals.

So where should they be focusing for the next twelve to eighteen months?

Four areas:

1. creating monitoring activities that determine whether promotional activities are staying on course;
2. developing appropriate and effective compliance activities in the clinical space;
3. renewing and revamping efforts around the Foreign Corrupt Practices Act; and
4. staying involved in areas where new transactions or strategies are being developed.

Of course, none of these topics are new, but it may be time for a fresh, renewed, and innovative compliance approach.

First, pharmaceutical companies have invested a significant amount of time, money, and effort in ensuring promotional activities are beyond reproach. These activities have created terrific focus on “getting it right.” Compliance organizations should now be focusing on monitoring the results of these activities, not the activities themselves. A risk-based approach, using a combination of data analysis and observation should be utilized. The traditional data should be used, such as the potential for off label. Traditional observations should be made through such action as field ride alongs. However, as payments to physicians become increasingly public, some area of the organization should be incorporating this data into its analyses on a proactive and routine basis. They should be looking for interesting and/or unintended correlations. This information should be incorporated into every risk analysis.

Second, many government officials have repeatedly articulated increasing their focus on clinical activities. This is a data rich and topic rich area, and in some respects the government has access to more and better data. Areas for compliance focus might include the collection and analysis of clinical trial data, the collection and analysis of adverse events, and the publication review process. These processes are large, complex, and in some cases, very distributed across the organization. For example, prior to publication, an article may be reviewed and modified numerous times and by many parts of an organization. There should be a control to ensure that the original meaning, data, and conclusions cannot get unintentionally modified in the process. Similar examples could be made about other clinical processes.

While compliance organizations have long been focused on FCPA, or more generally, anti-bribery and anti-corruption compliance activities, it is time for a renewed and enhanced review. In other industries, the government has recently used sophisticated investigational methods; in effect, they have set up stings. This is not a new approach, and has been used in the pharmaceutical industry in the past. Compliance organizations should be ensuring that every employee is very clear on the company’s position on bribery and corruption. Every employee should clearly understand where the bright lines are, and just as importantly, how to behave in the grey areas. To accomplish this, compliance should renew and refresh training activities in this area. Case-based training is particularly effective and can create productive dialog about the grey areas. Additionally, compliance leaders should be considering how they can monitor or test to ensure employees are behaving consistent with the law and the company’s values. This is absolutely critical in a time of pressure on results and/or organizational disruption.

Finally, compliance leaders should constantly keep their fingers on the pulse of the organizational dynamics within their companies. Where are new transactions being developed? Are controls being developed to keep pace with these new transactions? Is compliance being integrated into these processes as they are being developed? Where is the greatest amount of pressure on results? Are leaders sending balanced messages? Is there a future gap in earnings? What are the strategies for filling the gaps? Is there new leadership from outside the industry in an area? Someone who might not fully understand industry regulation? Are there new compensation structures? What might be any unintended consequences of those structures? Is there organizational disruption? What type of training/retraining might be valuable? Could organization disruption create a short-term mentality? Could this lead to undesirable behaviors? Would the established monitoring techniques detect these behaviors?

The industry has invested significantly in compliance efforts over the past ten years, and compliance professionals have matured into valuable contributors and business partners. Partners that help the business think through important strategic questions, integrate solid controls into processes, and create monitoring systems that prevent or detect problems. There is so much terrific work that has been accomplished; however, there is always room for improvement and innovation. Now more than ever, we need to reinforce, refresh and innovate those activities.